Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel

Davide Capodanno; Marie-Claude Morice; Dominick J Angiolillo; Deepak L Bhatt; Robert A Byrne; Roisin Colleran; Thomas Cuisset; Donald Cutlip; Pedro Eerdmans; John Eikelboom; Andrew Farb; C Michael Gibson; John Gregson; Michael Haude; Stefan K James; Hyo-Soo Kim; Takeshi Kimura; Akihide Konishi; Martin B Leon; P F Adrian Magee; Yoshiaki Mitsutake; Darren Mylotte; Stuart J Pocock; Sunil V Rao; Ernest Spitzer; Norman Stockbridge; Marco Valgimigli; Olivier Varenne; Ute Windhovel; Mitchel W Krucoff; Philip Urban; Roxana Mehran

doi:10.1016/j.jacc.2020.06.085

Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel

J Am Coll Cardiol. 2020 Sep 22;76(12):1468-1483. doi: 10.1016/j.jacc.2020.06.085.

Authors

Davide Capodanno¹, Marie-Claude Morice², Dominick J Angiolillo³, Deepak L Bhatt⁴, Robert A Byrne⁵, Roisin Colleran⁶, Thomas Cuisset⁷, Donald Cutlip⁸, Pedro Eerdmans⁹, John Eikelboom¹⁰, Andrew Farb¹¹, C Michael Gibson¹², John Gregson¹³, Michael Haude¹⁴, Stefan K James¹⁵, Hyo-Soo Kim¹⁶, Takeshi Kimura¹⁷, Akihide Konishi¹⁸, Martin B Leon¹⁹, P F Adrian Magee²⁰, Yoshiaki Mitsutake¹⁸, Darren Mylotte²¹, Stuart J Pocock¹³, Sunil V Rao²², Ernest Spitzer²³, Norman Stockbridge¹¹, Marco Valgimigli²⁴, Olivier Varenne²⁵, Ute Windhovel²⁶, Mitchel W Krucoff²⁷, Philip Urban²⁸, Roxana Mehran²⁹

Affiliations

¹ Division of Cardiology, Azienda Ospedaliero Universitario "Policlinico G. Rodolico-San Marco", University of Catania, Catania, Italy. Electronic address: dcapodanno@unict.it.
² Cardiovascular European Research Center, Massy, France. Electronic address: https://twitter.com/mc_morice.
³ Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.
⁴ Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/DLBhattMD.
⁵ Cardiovascular Research Institute Dublin, Mater Private Hospital, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland. Electronic address: https://twitter.com/robebyrne.
⁶ Cardiovascular Research Institute Dublin, Mater Private Hospital, Dublin, Ireland; Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
⁷ Département de Cardiologie, Centre Hospitalier Universitaire Timone and Inserm, Inra, Centre de Recherche en Cardiovasculaire et Nutrition, Faculté de Médecine, Aix-Marseille Université, Marseille, France. Electronic address: https://twitter.com/CuissetDr.
⁸ Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/DonaldCutlip.
⁹ DEKRA Certification, Arnhem, the Netherlands.
¹⁰ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
¹¹ U.S. Food and Drug Administration, Silver Spring, Maryland.
¹² Harvard Medical School, Boston, Massachusetts; Baim Institute for Clinical Research, Brookline, Massachusetts. Electronic address: https://twitter.com/CMichaelGibson.
¹³ London School of Hygiene and Tropical Medicine, London, United Kingdom.
¹⁴ Städtische Kliniken Neuss, Lukaskrankenhaus, Neuss, Germany.
¹⁵ Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
¹⁶ Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
¹⁷ Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
¹⁸ Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
¹⁹ Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: https://twitter.com/MartyMleon.
²⁰ U.S. Food and Drug Administration, Silver Spring, Maryland. Electronic address: https://twitter.com/dmylotte.
²¹ University Hospital and National University of Ireland, Galway, Ireland.
²² Duke Clinical Research Institute, Durham, North Carolina. Electronic address: https://twitter.com/SVRaoMD.
²³ Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Cardialysis, Clinical Trial Management and Core Laboratories, Rotterdam, the Netherlands. Electronic address: https://twitter.com/ernest_spitzer.
²⁴ Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/vlgmrc.
²⁵ Service de Cardiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France; Université Paris Descartes, Sorbonne Paris-Cité, Paris, France.
²⁶ Cardiovascular European Research Center, Massy, France. Electronic address: https://twitter.com/Urphi.
²⁷ Duke Clinical Research Institute, Durham, North Carolina; Duke University Medical Center, Durham, North Carolina. Electronic address: https://twitter.com/mwkrucoff.
²⁸ La Tour Hospital, Geneva, Switzerland.
²⁹ Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: https://twitter.com/Drroxmehran.

PMID: 32943165
DOI: 10.1016/j.jacc.2020.06.085

Abstract

Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative from the Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.

Keywords: high bleeding risk; percutaneous coronary intervention; trial design.

Publication types

Review

MeSH terms

Clinical Trials as Topic*
Hemorrhage*
Humans
Outcome Assessment, Health Care
Percutaneous Coronary Intervention*

Grants and funding

FS/20/25/34983/BHF_/British Heart Foundation/United Kingdom